Counterfeit items continue to pose a significant and growing problem with consumer packaged goods, especially for established brands. Because of their intrinsic capability to carry diverse coded information, nucleic acids have been used to provide a secure, cost effective and forensic method to help companies protect their intellectual property and brand. Typically, nucleic acids are applied to the commercial article by means that stabilize it to manufacturing processes, then the nucleic acid can be sequenced to verify the product's authenticity. Unique nucleic sequences must be synthesized for each coding identifier.
Linking identification of specimen container contents to patient identification is a critical unmet need in clinical lab diagnostics. Because of their intrinsic capability to carry diverse coded information and their innate and nearly ubiquitous presence in biological specimens, nucleic acids have been used to provide a secure forensic method to help diagnosticians ensure that sample identification is correct. Typically, a biological specimen with an identity in question may be matched to an individual's identity if the DNA that occurs naturally in the specimen and the DNA from a sample known to come from the individual are sequenced and matched. This process offers identification at a high level of certainty, but typically at high costs in terms of expense, effort, and time.
Likewise, microparticulate taggants have been used as means for authenticating products. For example, U.S. Pat. No. 7,874,489 disclosed using such taggants, combining taggants that have different detectable physical properties, wherein each combination of properties is used as an encoding bit to create codes. Similarly to nucleic acids, unique taggants with unique combinations of physical properties must be manufactured in order to increase the number and complexity of possible codes.
The detection of nucleic acids is widely employed for determining the presence and copy number of specific genes and known sequences. An important characteristic of nucleic acids is their ability to form sequence-specific hydrogen bonds with a nucleic acid having a complementary nucleotide sequence. This ability of nucleic acids to hybridize to complementary strands of nucleic acids has been used to advantage in what are known as hybridization assays, and in DNA purification techniques. In a hybridization assay, a nucleic acid having a known sequence is used as a probe that hybridizes to a target nucleic acid having a complementary nucleic acid sequence. Labeling the probe allows detection of the hybrid and, correspondingly, the target nucleic acid.
Because of their intrinsic capability to carry diverse coded information, nucleic acids have been used to provide a secure, cost effective and forensic method to help companies protect their intellectual property and brand. U.S. Pat. No. 5,139,812 discloses the use of nucleic acid sequences in ink for identifying an object with a probe. U.S. Pat. No. 5,451,505 uses nucleic acids as taggants. Such techniques also are not readily perceptible without the aid of special equipment, which develop the presence of such markers. U.S. Patent Application Publication No. 2005/0112610 discloses the use of nucleic acid sequences for identifying textiles. However, for each unique code it is required that a separate, unique target nucleic acid sequence be synthesized, increasing cost and decreasing practicality of the methods. Moreover, complex and expensive sequencing analysis has typically been required to identify such unique sequences.
The presently disclosed subject matter overcomes certain of the above limitations in Identif's Bio-Molecular Marker Covert system, which is based on a synthetic target nucleic acid sequence supplied as an ink. The Indentif product's label is imprinted with a customer-specific ink, which can be identified in the field by activating the marking with a pen that contains the mating strand. One of the half strands of DNA is accompanied by a “molecular beacon” fluorophore. When unmatched, the fluorophore is not visible. But when matched with a mating strand, it opens and the fluorophore becomes detectable. In contrast to Identif's technology, the signal in the presently disclosed subject matter does not require that either strand be synthesized with costly molecular beacon technology incorporated. Additionally, the methods of the present disclosure do not require synthesis of separate, unique target nucleic acid sequences for each customer-specific code, as is the case with Identif's method.
Applied DNA Sciences offers the SigNature™ Program based on APDN's plant-derived DNA sequences. Botanical DNA is encrypted into inks, paper, thread, holograms and other mediums, or printed in a botanical DNA SigNature logo that highlights the word “Nature”. The logo has been designed to contain embedded botanical DNA, for overt detection and forensic authentication purposes. For real-time detection, APDN offers a proprietary SigNature DNA detection pen that is applied over the DNA-embedded SigNature logo, prompting a reversible color change. No details have been uncovered relating to the chemistry of detection, but the APDN method is subject to the same limitations as those identified for Identif's.
Thus, there is an unmet need for more tamperproof authentication technology that is also cost effective. The present disclosure provides such improved authentication technology.